NCT06072924 K01 Impacts of Lingual Endurance Exercise
| NCT ID | NCT06072924 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Cincinnati |
| Condition | Dysphagia |
| Study Type | INTERVENTIONAL |
| Enrollment | 70 participants |
| Start Date | 2023-09-01 |
| Primary Completion | 2027-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 70 participants in total. It began in 2023-09-01 with a primary completion date of 2027-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this clinical trial is to learn whether a tongue endurance exercise program can improve swallowing function in adults with dysphagia after a stroke. It also aims to explore how this exercise may affect brain structure and connectivity involved in swallowing. The main questions it aims to answer are: Primary Aim: Does lingual endurance exercise improve swallowing function compared to a sham therapy? Secondary Aim: Does lingual endurance exercise lead to changes in brain structure or neuroplasticity, as measured by MRI? Researchers will compare a group receiving tongue endurance exercises to a sham therapy group to see whether the treatment improves tongue function, swallowing. Participants will: * Complete a baseline swallowing assessment and MRI * Be randomly assigned to either the lingual exercise or sham therapy group * Complete 8 weeks of home-based tongue exercise therapy * Return for follow-up swallowing assessments * A subgroup of participants will complete a pre-treatment and post-treatment MRI.
Eligibility Criteria
Inclusion Criteria: * 1\) 3-6 months since most recent diagnosis of ischemic, confirmed from clinical imaging) with or without small hemorrhagic transformation (HI-1) * 2\) English Speaking Exclusion Criteria: * 1\) ≤18 years of age * 2\) history of dysphagia prior to or after the stroke caused by any of the following conditions: gastrointestinal disease, traumatic brain injury, head and neck cancer, surgery involving the pharynx or larynx * 3\) history of other neurological disease (i.e. multiple sclerosis, ALS, Parkinson's, dementia). 5\) 5) History of temporomandibular joint and muscle disorders (also known as TMJ).
Contact & Investigator
Brittany N Krekeler, PhD
PRINCIPAL INVESTIGATOR
University of Cincinnati
Frequently Asked Questions
Who can join the NCT06072924 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Dysphagia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06072924 currently recruiting?
Yes, NCT06072924 is actively recruiting participants. Contact the research team at hopkiak@ucmail.uc.edu for enrollment information.
Where is the NCT06072924 trial being conducted?
This trial is being conducted at Cincinnati, United States.
Who is sponsoring the NCT06072924 clinical trial?
NCT06072924 is sponsored by University of Cincinnati. The principal investigator is Brittany N Krekeler, PhD at University of Cincinnati. The trial plans to enroll 70 participants.